Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs [3] - The company's lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell therapy derived from the bone marrow of young, healthy adult donors [3] - Lomecel-B™ has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [3] Pipeline and FDA Designations - Longeveron is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [3] - The HLHS program has received three important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [3] - The Alzheimer's disease program has received two significant FDA designations: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [3] Upcoming Financial Results - Longeveron will report its full-year 2024 financial results and provide a business update on February 28, 2025, after U.S. financial markets close [1] - A conference call and webcast will be held on the same day at 4:30 p.m. ET [1][2]

Core Viewpoint - Longeveron Inc. has received approval from the WHO for the non-proprietary name "laromestrocel" for its cellular therapy Lomecel-B™, marking a significant milestone in its development and potential commercialization [1][2][6]. Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with its lead product being Lomecel-B™, an allogeneic medicinal signaling cell therapy derived from the bone marrow of young, healthy adult donors [4][6]. - The company is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [4]. Product Details - Lomecel-B™ is a proprietary, scalable cellular therapy being evaluated for Alzheimer's disease and HLHS, a rare pediatric disease [1][6]. - The therapy utilizes medicinal signaling cells (MSCs) that play a crucial role in the body's repair mechanisms, potentially offering anti-inflammatory and regenerative benefits across various diseases [3][4]. Regulatory Designations - Lomecel-B™ has received multiple FDA designations: Regenerative Medicine Advanced Therapy (RMAT) and Fast Track for mild Alzheimer's disease, and Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS [2][4].

Wa'el Hashad Wa'el Hashad, CEO, Longeveron Cellular therapy Lomecel-B™ has been granted an International Non-proprietary Name (INN) of “laromestrocel” on the INN List issued by the World Health Organization (WHO)Lomecel-B™ is a proprietary, scalable, allogeneic cellular therapy being evaluated in Alzheimer’s disease and hypoplastic left heart syndrome (HLHS), a rare pediatric disease and orphan indicationLomecel-B™ first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced T ...

Company Overview - Longeveron Inc. is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs [3] - The company's lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell therapy derived from the bone marrow of young, healthy adult donors [3] - Lomecel-B™ has multiple potential mechanisms of action, including pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair effects, with applications across various disease areas [3] Pipeline and FDA Designations - Longeveron is pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and aging-related frailty [3] - The HLHS program has received three important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation [3] - The Alzheimer's disease program has received two FDA designations: Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [3] Upcoming Events - Longeveron will participate in the Emerging Growth Virtual Conference on February 18-19, 2025, with a presentation scheduled for February 19, 2025, from 3:10 to 3:20 p.m. ET [1] - The webcast for the conference presentation will be accessible on the company's website, with a replay available for 180 days post-conference [1]

MIAMI, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that it will participate in the Emerging Growth Virtual Conference taking place December 4-5, 2024. Details for the Company’s presentation: Date:December 5, 2024Time:12:00 – 12:30 p.m. ET   The webcast for this conference presentation may be accessed at the “Events and Pre ...

Findings offer potential mechanistic and clinical insights in the development of cellular therapy LomecelB™ for mild Alzheimer's disease (AD) Lomecel-B™ capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild AD Immunomodulatory and pro-vascular effects of Lomecel-B™ in mild AD potentially driven by ability to exert MMP14 inhibition which may protect TIE2 receptor integrity in human AD patients MIAMI, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clin ...

Oral presentation highlights findings that patients treated with Lomecel-BTM in ELPIS I, in an openlabel follow-on study, experienced 5-year survival after stage 2 Glenn surgery of 100% with none requiring heart transplant; this compared to the largest data set from the Single Ventricle Reconstruction Trial which showed 83% survival, with a 5.2% heart transplantation rate ELPIS I met its primary endpoint of safety through 1-year post-treatment, with 100% survival rate, 100% transplant-free and patients main ...

MIAMI, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that its submission entitled "Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy" has been selected for oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting to be held October 27-28, 2 ...

MIAMI, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that it will participate in the 3rd Annual ROTH Healthcare Opportunities Conference taking place October 9, 2024 in New York City, including Wa'el Hashad, Chief Executive Officer, speaking on the panel "Emerging Frontiers in Neuroscience" and investor 1x1 meetings. The Lon ...

Exploring potential partnership and strategic opportunities for the Company's cellular therapy program in Alzheimer's disease Highlighting the Company's cellular therapy contract development and manufacturing business at its 15,000 square feet facility with 8 current Good Manufacturing Practice (cGMP) cleanroom suites MIAMI, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and ch ...